Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
- Conditions
- Breast CancerLung CancerNeurotoxicityOvarian CancerProstate CancerUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00078845
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
RATIONALE: Amifostine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy.
PURPOSE: This phase II trial is studying how well amifostine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received paclitaxel for solid tumors.
- Detailed Description
OBJECTIVES:
Primary
* Determine the percentage of patients with solid tumors who have persistent paclitaxel-induced peripheral neuropathy who benefit, defined as a decrease of at least 20% on their FUNCTIONAL ASSESSMENT OF CANCER THERAPY/ GYNECOLOGIC ONCOLOGY GROUP NEUROTOXICITY (FACT/GOG-Ntx) FACT-GOG-NTX score, from treatment with subcutaneous amifostine.
* Determine whether there is sufficient evidence of reversal activity of this drug in these patients to justify a phase III study.
Secondary
* Compare the acute toxic effects of this drug administered subcutaneously in these patients vs IV administrations of this drug historically and/or during the GOG-0192 study.
* Determine the capability of the Weinstein Enhanced Sensory Test to provide objective, quantitative evidence for improvement in patients who have subjective improvement as self-reported on the FACT-GOG-NTX scale.
* Determine whether any benefit in patients treated with this drug is transient or lasts at least 8 weeks.
OUTLINE: This is an open-label, multicenter study.
Patients receive amifostine subcutaneously three times weekly for 4 weeks in the absence of symptom progression or unacceptable toxicity. Patients achieving a complete or partial response receive an additional 4 weeks of therapy.
Neuropathy symptoms are assessed using the FACT-GOG-NTX questionnaire administered at baseline, weekly during therapy, and at 12 weeks and the Weinstein Enhanced Sensory Test administered at baseline and at 4, 8, and 12 weeks.
Patients are followed at 12 weeks.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-20 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Amifostine Amifostine 500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.
- Primary Outcome Measures
Name Time Method Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale 12 weeks 11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
University of Texas M.D. Anderson CCOP Research Base
🇺🇸Houston, Texas, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
🇺🇸Racine, Wisconsin, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Christus St. Frances Cabrini Center for Cancer Care
🇺🇸Alexandria, Louisiana, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States